Senior Associate II, Quality Audits

Biogen

. Support internal GMP/GDP and ISO 13485 audits across Europe and Rest-of-World operations as a contributing auditor .

Posted 10/5/2026full-timeBaar • SwitzerlandSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in conducting audits within regulated environments, ensuring compliance with GxP and ISO 13485 standards. Proficient in documentation, communication, and collaboration with cross-functional teams to support audit activities and inspection readiness.

Highest-signal resume keywords

GMP/GDP AuditingISO 13485 ComplianceGxP FrameworksAudit DocumentationInspection Readiness

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

AuditingDocumentation ReviewCAPA TrackingAudit ReportingRegulatory Compliance

Soft Skills

Interpersonal SkillsCollaborationEffective Communication

Industry Keywords

PharmaceuticalBiotechnologyMedical DeviceEMA ExpectationsAudit Activities

About the role

Key responsibilities & impact

Support internal GMP/GDP and ISO 13485 audits across Europe and Rest-of-World operations as a contributing auditor
Assist in external audits of suppliers, contract manufacturers, contract laboratories, and service providers under guidance
Document audit activities and support preparation of audit reports and records
Track and review audit responses and CAPAs for completeness
Support inspection readiness activities and maintain audit documentation
Collaborate with site SMEs and Quality teams during audit execution to gather documentation and clarifications
Participate in supplier and partner audits to assess compliance with GxP and ISO 13485 requirements
Collect and review documentation from external partners during audit activities
Communicate audit observations and follow-up expectations effectively

Requirements

What you’ll need

Bachelor of Science in Life Science, Engineering, or related technical discipline
Minimum of 7 years experience in a regulated pharmaceutical, biotechnology, or medical device environment
Minimum of 3 years progressive auditing experience, including leadership of complex, multi-country audits
Demonstrated expertise in EMA expectations, ISO 13485, and global GxP frameworks
Proficiency in English, both written and spoken
Experience with inspection readiness activities preferred
Advanced terminal degree (MD, PhD, PharmD) desirable
Strong interpersonal skills to facilitate collaboration across various teams preferred

Benefits

Comp & perks

Learning, growth, and opportunities to expand skills
Inclusive and belonging-focused workplace culture
Stability and resources of an established biotechnology company
Opportunity to make significant individual contributions
Work on life-changing medicines